Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0536-04

Four Shooter Saeed Multi-Band Ligator

Wilson-Cook Medical Inc. / initiated 2004-01-15 / Terminated / root cause: labeling and UDI

Wilson-Cook Medical Inc began a recall of Four Shooter Saeed Multi-Band Ligator on . The reason FDA records is "Product label lacks the symbols specifying the meaning of the manufacturing and expiration date". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0536-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Wilson-Cook Medical Inc.
Product
Four Shooter Saeed Multi-Band Ligator
Product code
FHN Ligator, Hemorrhoidal
Reason for recall
Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
Consignee was notified by letter, hand delivered by Cook sales representative on 1/19/2004.
Quantity in commerce
3 units
Distribution
All units were shipped to one medical facility in CA
Product codes and lots
Reorder/Catalog number MBL-4-XL, Lot W1842922